Topic: Cancer, Gastroenterology
Conditions
Interventions
Participants will have two gastroscopies 4-10 weeks apart – one using mapping biopsies (current practice) and one using acetic acid. We will monitor how many agree to participate and reasons for withd
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. Biopsy proven Barrett’s metaplasia 3. At least 2cm of Barrett’s metaplasia (C0 M2) 4. Willing and able to give informed consent Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Less than 2cm (C0 M2) of Barrett’s metaplasia 2. Significant oesophagitis 3. Known or prior oesophageal cancer 4. Known or prior oesophageal dysplasia (indefinite for dysplasia CAN be included) 5. Previous endoscopic therapy 6. Known allergy to acetic acid 7. Previous inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months 2. To assess participant acceptability of the study design through quantitative measures related to study procedures and in-depth qualitative feedback 3. To identify the degree of difference in dysplasia (pre-cancerous changes) detection rates between acetic acid gastroscopy (targeted biopsies) and standard gastroscopic practice (non-targeted mapping biopsies) to inform the power calculation for a definitive study 4. Feasibility of training and implementation of acetic acid guided dysplasia detection technique 5. To explore the acceptability to clinicians and patients of the concept of using a targeted biopsy technique for surveillance instead of non-targeted, mapping biopsies 6. To identify potential facilitators and barriers to recruitment and retention for the definitive trial 7. To describe adverse events for the two methods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the feasibility of recruiting 200 Barrett's surveillance patients in 18 months 2. To assess participant acceptability of the study design through quantitative measures related to study procedures and in-depth qualitative feedback 3. To identify the degree of difference in dysplasia (pre-cancerous changes) detection rates between acetic acid gastroscopy (targeted biopsies) and standard gastroscopic practice (non-targeted mapping biopsies) to inform the power calculation for a definitive study 4. Feasibility of training and implementation of acetic acid guided dysplasia detection technique 5. To explore the acceptability to clinicians and patients of the concept of using a targeted biopsy technique for surveillance instead of non-targeted, mapping biopsies 6. To identify potential facilitators and barriers to recruitment and retention for the definitive trial 7. To describe adverse events for the two methods | — |
Countries
United Kingdom
Outcome results
None listed